Clinical Trials Roundup—Week of 11/02
Mucopolysaccharidosis Patients Show Improvement With Alpha-L-Iduronidase Enzyme
BioMarin Pharmaceutical, Inc. and Genzyme General have reported that patients with the fatal genetic disorder mucopolysaccharidosis I (MPS-I) showed substantial improvement when treated with the enzyme alpha-L-iduronidase in a recent clinical trial.
MPS-I results from a genetic deficiency in the production of alpha-L-iduronidase, a key enzyme required for the progressive breakdown of complex carbohydrates found in all cells of the body. Data from the trial demonstrated that alpha-L-iduronidase replacement therapy reduced clinical measurements of the disease.
For more information: Dr. John C. Klock, Glyko Biomedical, Ltd., telephone: 415-382-6653.
Inflazyme To Begin Testing "Molecule From The Sea"
Inflazyme Pharmaceuticals Ltd. has received sufficient quantity of its lead asthma product IPL 576,092 to complete its extended preclinical toxicology program and commence clinical trials. The Company expects IPL 576,092 to enter 14-day animal toxicology studies with Inveresk Research (Edinburgh, Scotland) by the end of the year.
IPL 576,092 has been developed from a natural compound isolated from a sea sponge obtained from the ocean off the coast of Papua New Guinea. The molecule displays efficacy comparable to that seen with inhaled glucocorticoids of asthma in animal models, but without the side effects associated with these products.
Flamel Announces Results Of Genvir Study
Flamel Technologies has released preliminary results from its Phase III clinical study of Genvir, a controlled-release formulation of acyclovir based on Micropump Technology, for acute genital herpes.
The double-blind Phase III study compared Genvir with Zovirax, the Glaxo Wellcome formulation of acyclovir, and involved 419 patients with recurrences of acute genital herpes. Results indicate that lesions were healed in 53.6% of Genvir-treated patients as compared to 45.7% of Zovirax-treated patients.
For more information: Dr. Gerard Soula, CEO, or Dr. Philippe Vivet, Flamel Technologies, S.A., telephone: 33-472-78-3434 or 704-528-1087.
Trimeris Releases T-20 Trial Results
Trimeris, Inc. has released its Phase I/II clinical trial results of T-20, a fusion inhibitor that blocks the entry of the HIV virus into cells. According to Trimeris, T-20 produces a potent antiviral effect even in HIV-infected subjects who have been treated with other anti-viral agents.
For more information: Matthew A. Megaro, Trimeris, Inc., telephone: 919-419-6050.
Neurobiological Technologies Initiates Phase IIB Human Memantine Trial
Neurobiological Technologies, Inc. has initiated a Phase IIB human clinical trial to evaluate Memantine as a treatment for painful peripheral diabetic neuropathy. The trial will evaluate the ability of Memantine to relieve chronic pain due to peripheral neuropathy or nerve damage, particularly nocturnal pain that frequently interferes with sleep.
Memantine is an orally available compound that appears to restore the function of impaired neurons by modulating activity of the NMDA receptor, integral to the membranes of such cells.
For more information: Victor Libet, Russell-Welsh, Inc., telephone: 650-312-0700, ext. 25.
SciClone Announces Phase II Trial Results Of Hepatitis B Treatment
SciClone Pharmaceuticals has announced the results of a Phase II clinical trial in chronic hepatitis B patients of its Zadaxin thymosin alpha 1 plus famciclovir, a nucleoside analogue. In the trial, combination therapy resulted in hepatitis e antigen seroconversion, or the elimination of viral replication, in a clinically significant number of patients.
For more information: Shawn K. Singh, senior VP, SciClone, telephone: 650-358-1451.